What are the responsibilities and job description for the Regulatory Affairs Manager position at Par Pharmaceutical an Endo International Company?
Job Summary - a concise overview of the job | |||
Reporting to the Regulatory Affairs (RA) Liaison Director, the incumbent has primary responsibility for management of day-to-day regulatory activities and providing regulatory requirements and strategy for assigned projects. The incumbent will work closely with the project teams and RA team in order to implement and execute strategies aligned with Endo business objectives. The individual will also closely monitor the evolving regulatory landscape for issues impacting Endo’s business.
All incumbents are responsible for following applicable Division & Company policies and procedures. | |||
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. | |||
No direct budget management responsibilities other than prudent stewardship of Company resources in accomplishing assigned responsibilities and individual objectives. | |||
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Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time | |||
Accountability | Responsibilities | % of Time | |
Subject Matter Expertise
| § Responsible for providing regulatory support, managing regulatory activities, and advising on regulatory requirements and strategy during all stages of drug development, for assigned products. § Manage the planning, preparation, and coordination of technical content review for regulatory submissions and ensure schedules and established timelines are met. § Manage, draft, and aid in securing internal approval of FDA meeting requests and briefing books. § Manage labeling documents, including preparing package inserts, as well as aiding in quality control of labeling submissions. § Interact with key regulatory agencies as appropriate with guidance from the RA Liaison Director. § Represent Regulatory Affairs as needed across the Company or with external partnerships/consortiums | 70% | |
Regulatory Compliance | § Collect and evaluate regulations and guidance documents with assessment for their impact on the company. Manage communication of regulatory issues to functional. § Manage assigned products to ensure compliance with applicable regulations. § Maintain a high level of understanding of current global regulatory requirements. | 20% | |
Process Effectiveness/ Efficiency | § Assist in the establishment and maintenance of Regulatory Affairs Operating Procedures and process. § Liaise with other Endo International plc regulatory colleagues or teams as needed. | 10% | |
Total | 100% | ||
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Qualifications | |||
Education & Experience | Minimal acceptable level of education, work experience and certifications required for the job | ||
§ Must have Bachelor’s degree. § Minimum 7 years pharmaceutical drug development experience with 5 years direct regulatory experience. | |||
Knowledge | Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. | ||
§ Strong knowledge in regulations/guidelines governing development of pharmaceuticals is required. | |||
Skills & Abilities | Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. | ||
§ Excellent communication and proven negotiation skills. § Ability to effectively work in a team environment and develop peer relationships. § Ability to work independently in a fast paced environment. § Ethics and Values. § Ability to influence those over whom there is no immediate supervisory capacity to achieve objectives. | |||
Physical Requirements | Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. | ||
§ Business travel (5% of time). | |||
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Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change o